A Language Intervention Study of Preterm Infants

Language Development Clinical Trial

Official title:

Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03688386
• Other study ID #: Pending
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.

Description:

This project aims to examine how an educational reading intervention in the NICU can impact preterm infant language development and examine the impact of reading on mother-infant autonomic systems. Investigators plan to determine the effects of parent reading in addition to standard caretaking and holding on preterm infants, between 23 to 31 weeks gestation hospitalized in the Women & Infants NICU, on adult word count, infant vocalizations, conversational turns through audio recording obtained over 3 separate days when the infant is corrected to 32, 34 and 36 weeks. Investigators aim to determine the effect of parent reading on maternal and infant heart rate variability before, during, and after the shared reading intervention through video and a single channel electrocardiographic recording over the same 3 separate days as the LENA recording. Additionally, investigators aim to determine the effect of parent reading on maternal stress and perceived well-being in the NICU through a validated questionnaire and to determine parent satisfaction of a NICU reading intervention through a parent questionnaire completed prior to infant discharge and at the 12 month follow up visit. Secondary outcomes include determining the effect of parent reading on infant DNA methylation of the several genes through two saliva samples collected from the infant prior to study and post study enrollment and examine its relationship with infant stress and self-regulation based on a neurobehavioral exam performed at 36 weeks corrected age. Final outcomes include examination of the long-term effect of inpatient shared reading education on infant receptive and expressive language development at 12 and 24 months. Investigators hope this research will contribute to the growing research supporting early language development in preterm infants and its impact on maternal-infant well-being.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: June 30, 2021
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Weeks to 31 Weeks

Eligibility

Inclusion Criteria:

• 21-31 week infants, medically stable infants, English speaking mothers over 18 years old

Exclusion Criteria:

• Intubated or medically unstable, major congenital anomalies, non English speaking

Related Conditions & MeSH terms

• Language Delay
• Language Development
• Language Development Disorders
• Maternal Behavior
• Mother-Infant Interaction

Intervention

Behavioral:
• Reading intervention
Written packet with 3 lessons. The first lesson includes how to begin to read and talk to their baby. The second lesson includes reading or talking about the day using parentese talk. The third lesson includes continuing to engage with the baby through interactive reading.
• Infant bonding
Written packet with 3 lessons. The first lesson includes skin-to-skin and learning about their baby. The second lesson includes learning readiness cues and participation in feeding times. The third lesson includes developing routines and playing games.
• LENA recording
The LENA device provide 16 hours of language recordings placed inside an infant vest. The recordings are uploaded to a computer which analyzes total adult word counts, infant vocalizations, conversational turns, background noise, and silence.
• LENA linguistic feedback
LENA recordings of adult word counts, infant vocalizations, and conversational turns will be provided in printed form after each recording with review of each recording and progress over time.
• LENA summary
All 3 LENA recording summaries of adult word counts, infant vocalizations, and conversational turns will be summarized in printed form and provided to mother at discharge.

Locations

Country	Name	City	State
United States	Women and Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (4)

Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10. — View Citation

Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20. — View Citation

Lariviere J, Rennick JE. Parent picture-book reading to infants in the neonatal intensive care unit as an intervention supporting parent-infant interaction and later book reading. J Dev Behav Pediatr. 2011 Feb-Mar;32(2):146-52. doi: 10.1097/DBP.0b013e318203e3a1. — View Citation

Lester BM, Marsit CJ, Giarraputo J, Hawes K, LaGasse LL, Padbury JF. Neurobehavior related to epigenetic differences in preterm infants. Epigenomics. 2015 Oct;7(7):1123-36. doi: 10.2217/epi.15.63. Epub 2015 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DNA methylation	Understand DNA methylation pattern differences of genes of before and after study participation.	Enrollment and 36 weeks
Primary	LENA Counts	Adult word counts, conversational turns, and infant vocalizations from each recording	Change from 32 week language counts to 36 week language counts
Secondary	Neonatal Intensive Care Unit Network Neurobehavioral Scale profile	A validated neurologic assessment of infant neurobehavioral, neurologic and stress responses, and regulatory capacities. The following summary scores and their minimum and maximum scores are as follows: habituation (1-9), attention (1-9), handling (0-1), quality of movement (1-3), regulation (1-9), non optimal reflexes (0-12), asymmetric reflexes (0-7), stress/abstinence (0-1), arousal (1-9), hypertonicity (0-5), hypotonicity (0-3), excitability (0-9), lethargy (0-10). Higher scores indicate the summary score, for example a higher hypertonicity score indicates increased muscle tone whereas a higher hypotonicity score indicates decreased muscle tone. Summary scores are compared to normative scores for high risk preterm infants to compare overall neurobehavior.	36 weeks
Secondary	Bayley Scales of Infant and Toddler Development, Third Edition	Individual assessment used to assess development of infants between 1 to 42 months of age. Domains and their minimum and maximum scores are as follows: adaptive behavioral (40-160), cognitive 55-145), language (47-153), motor (46-154), and social emotional (55-145). Scores can be used to assess infants progress over time.	12 months and 24 months
Secondary	Maternal Well-Being	Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being	36 weeks
Secondary	Perception of reading and infant bonding	Parent survey regarding her experience in the NICU with reading, curriculum, and future plans to read to her infant	36 weeks and 12 months